INTELECT 2738 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-04 for INTELECT 2738 * manufactured by Djo, Llc.

Event Text Entries

[20653709] The patient had received electrical stimulation to left shoulder with a cervical hot pack placed on the upper trapezius region. Electrical stimulation was turned up to a comfortable level per patient reports and no muscle twitching was noted. The patient returned five days later and pointed to lateral deltoid and 3 wounds were noted with the largest measuring 2cm x 1cm. All wounds were clean, closed, with scabbing noted and no drainage. The largest wound was noted to have clean and well defined margins with the scabbing noted more medially. Margins appeared pink and not red in color. No wounds were noted where other electrodes were placed (left upper trapezius, anterior deltoid under incisions from surgery, and posterior deltoid). The patient stated that he had forgotten that his wife had used a muscle rub on his shoulder and he forgot to inform us. Patient was asked if he said anything to the rehab technician who took him off of the machine. He said he had not reported anything or used the buzzer (given instructions to use in pain or discomfort for any reason) because he said he realized it later. Patient was asked if he had any significant discomfort while the electrodes were on him and he said he thought it was a hot pack. He stated his wife noted the burns on his arm when he returned home. The patient stated that his wife had used a muscle rub on him prior to coming for treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3775171
MDR Report Key3775171
Date Received2014-04-04
Date of Report2014-04-04
Date of Event2014-03-28
Report Date2014-04-04
Date Reported to FDA2014-04-04
Date Reported to Mfgr2014-04-28
Date Added to Maude2014-04-28
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameINTELECT
Generic NameSTIMULATOR, ULTRASOUND AND MUSCLE
Product CodeIPF
Date Received2014-04-04
Model Number2738
Catalog Number*
Lot Number*
ID Number*
OperatorOTHER
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 92081 US 92081


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-04

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